The Bill is, of course, necessary to ensure that, in the absence of the European regulations under which we operate until the end of the implementation period, there are effective ways to regulate medicines and medical devices. Even under the current regulatory arrangements we have seen some patients face real difficulties, so it is vital that we get this right, as others have said.
The Minister will be aware that I and many hon. Members across the House have been working with the National Society for Phenylketonuria, or PKU, through the all-party group, to ensure that people with PKU have access to Kuvan, a drug widely available in many other countries. It feels like that has been a pretty hard slog at times, and we have not got there yet. I pay tribute to the NSPKU and, in particular, to Kate Learoyd and Caroline Graham, who have done such a lot of work to get the all-party group established and keep it very lively.
How much more difficult must it be for those people living with PKU—children and adults—to know that there is a drug that would help many of them, but to find that it is not available, than it is for us to see that situation for our constituents? In introducing the debate, the Secretary of State made a great deal of our new powers to act under these arrangements, and I hope very much that that means that Kuvan will become available very quickly. More broadly, I ask the Minister what this Bill will mean for patients with PKU who are hoping to have that drug made available, and how it will affect new therapies and drugs that are in development to treat PKU. How will they be licensed and made available?
Many rare diseases require a large pool of patients to have effective clinical trials of new treatments, and again I ask the Minister if she can say how she will ensure that UK patients can take part in those trials and benefit from innovative treatments. This will be important to the community of patients with rare diseases, not only those with PKU, and I know that there will be great anxiety about the issue of translating EU regulation into UK law and making sure that issues of access, safety and clinical trials are fully covered and regulated. UK patients with rare diseases must not be disadvantaged by separate licensing and trial arrangements, and I ask the Minister to comment on that.
Secondly, this legislation clearly impacts on the role of the MHRA. At this point, I want to mention the great work of Emma Murphy and Janet Williams, who have worked so hard on the issue of fetal valproate spectrum disorder, to which my hon. Friend the Member for Leicester South (Jonathan Ashworth) referred. They have found that,
despite the devastating impact arising from women with epilepsy being prescribed the drug valproate during pregnancy and despite these problems being known about among the medical profession for many years, that drug is still being prescribed, sometimes in unmarked boxes, and is still causing damage to babies whose mothers have taken the drug. I hope that this new system will ensure that the regulations are strengthened to ensure that that cannot happen in any case in the future—the will is there to do it. This is happening even after advice to doctors and pharmacists had already been given as a result of the fetal valproate syndrome campaign, so we need action to resolve that straightaway.